Summary:
Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of immunohematology quality control (QC) records and Ortho MTS ID-Micro Typing System instructions for use and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 9:00 am on 2 /10/2023, the laboratory failed to perform a negative control on three MTS gel cards used to perform ABO, D (Rho) typing and unexpected antibody screen testing on one out of one patient performed on 11/21/2022. The findings include: 1. On 11/21/2022, the laboratory used the A/B/D monoclonal and reverse grouping gel card (lot number 050622037-12, expiration date 2/20/23) to perform patient ABO and D(Rho) typing on patient identifier #1. 2. On 11/21/2022, the laboratory used A/B/D monoclonal grouping gel card (lot number 062022053-02, expiration date 4/18/23) to perform donor unit ABO and D(Rho) typing confirmation. 3. On 11/21/2022, the laboratory used Anti-IgG (Rabbit) gel card (lot number 101822001-05, expiration date 7/25/23) to perform unexpected antibody identification testing on patient identifier #1. 4. The Ortho MTS ID-Micro Typing System instructions for use for each of the gel cards state that a positive and negative control must be testing each day of use. 5. On 11/21 /2022, the laboratory did not perform a negative control for the above listed gel cards. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --